BEUDAMED
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    BALLOON THERMODILUTION CATHETER #7164&

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896

    FDA 510(k)
    FDA Class 2 ·Immunology

    CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014

    UNKNOWN DEPUY SIGMA SZ 4 STAB TIB INSERT

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code JWH·November 8, 2012

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·August 26, 2010

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012